Trials / Completed
CompletedNCT04314050
Comparison of Tramadol and Dexmedetomidine in the Prevention of Urinary Catheter Discomfort in Urinary Surgery
Comparison of Different Strategies in Preventing Discomfort Due to Urine Catheter in Urinary Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Ankara Diskapi Training and Research Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
The investigators aimed to compare the effects of tramadol and dexmedetomidine, which are commonly used in anesthesia, on preventing catheter-related bladder discomfort.
Detailed description
Urinary catheterization is an attempt frequently used in many surgeries, emergency services or intensive care units, especially urinary surgeries to facilitate urine output or evaluate urine output. However, as a result of urinary catheter application, most patients may develop some symptoms like pain, burning sensation and the urge to urinate constantly in the suprapubic region that the investigators call this catheter-related bladder discomfort (CRBD). The incidence of CRBD can increase 47 to 90% in the postoperative period. The main reason of CRBD is involuntary contractions caused by muscarinic receptors, especially type 3 (M3) receptors. Therefore, antimuscarinic drugs are used to prevent and treat CRBD. Studies have shown that many drugs such as ketamine, tolterodine, oxybutynin, gabapentin, pregabalin, butylscopolamine, tramadol, dexmedetomidine are effective in preventing CRBD. Their common feature is antimuscarinic effects. However, no definitive conclusion could be reached for routine use, due to the low number of samples in the studies, surgical differences or some anticholinergic and sedative side effects. Additionally, oxybutynin, tolterodine, gabapentin, and pregabalin are only preoperatively administered orally. So more research is needed to find the ideal agent to prevent CRBD. Tramadol is frequently used for moderate pain in surgeries. It is a centrally acting synthetic opioid analgesic that has an inhibitory effect on M1 and M3 muscarinic receptors. Tramadol has proven to be effective in reducing the severity and frequency of ICBR in intraoperative use. However, like other opioids, it can have side effects such as nausea-vomiting and sedation. Dexmedetomidine is a selective alpha-2 adrenoceptor agonist that has analgesic, sympatholytic and sedative properties. In recent studies, it has been reported that dexmedetomidine is associated with the pathophysiology of CRBD by inhibiting type-3 (M3) muscarinic receptor which has beneficial effects in preventing CRBD in intraoperative use. Dexmedetomidine decreases the frequency of CRBD by 30%. The first purpose of the study is to compare the effects of dexmedetomidine and tramadol on CRBD. Secondarily, the investigators aimed to compare them for their side effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tramadol | tramadol and paracetamol will perform |
| DRUG | Dexmedetomidine | dexmedetomidine and paracetamol will perform |
| OTHER | control | paracetamol will perform |
Timeline
- Start date
- 2020-03-10
- Primary completion
- 2020-06-10
- Completion
- 2020-07-10
- First posted
- 2020-03-18
- Last updated
- 2021-11-09
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04314050. Inclusion in this directory is not an endorsement.